Exchangeable core biopsy needle

ABSTRACT

The present disclosure provides an adjustable delivery handle system for interchangeably delivering a needle to a biopsy site. The adjustable delivery handle system includes a delivery handle having an inner hub housing component configured to interchangeably receive a needle subassembly that can be inserted into and withdrawn from the proximal handle member. The needle subassembly includes a biopsy needle having a distinct tissue collection distal end configured to maximize tissue sampling yield and collect a cohesive unit of sampled tissue. The distal end of the needle includes first and second tip portions extending therefrom and radially opposing one another. The first tip portion has a length greater than the second tip portion, thereby resulting in an increased surface area of a curvilinear cutting edge extending from the first tip portion to the second tip portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of, and priority to, U.S.Provisional Patent Application Nos. 62/030,841 and 62/030,828, both ofwhich were filed on Jul. 30, 2014. This application is related to U.S.patent application Ser. No. ______, filed on ______. The entire contentsof each of the above applications are hereby incorporated herein byreference.

FIELD OF THE INVENTION

The present disclosure generally relates to biopsy devices, and, moreparticularly, to a biopsy needle configured for collecting tissue,fluid, and/or cell samples in conjunction with minimally-invasiveprocedures, such as endoscopic biopsy procedures.

BACKGROUND

In the practice of medical diagnostics, it is often necessary to performa biopsy to remove a sample of a patient's tissue or fluid forpathological study. For example, biopsies can be useful in diagnosingvarious forms of cancer and other diseases affecting a localized area oftissue. Biopsy procedures may be used to take tissue and/or fluidsamples from muscles, bones and organs, such as the liver or lungs. Insome instances, a biopsy sample may be obtained by invasive surgicalprocedures. However, minimally invasive biopsy procedures are oftenpreferred, such as fine needle aspiration and fine needle biopsy becausesuch procedures are less traumatic to the patient.

Both fine needle aspiration (FNA) and fine needle biopsy (FNB)procedures generally include the use of a biopsy needle for collectingthe target sample. FIGS. 1 and 2 are provided to illustrate oneembodiment of a biopsy needle 100 currently available for use in biopsyprocedures. As shown, the needle 100 includes a shaft 102 portionextending from a proximal end (not shown) to a distal cutting end 104 ofthe needle 100. The distal cutting end 104 includes a beveled leadingend 106 resulting in a relatively sharp tip portion 110 used forpuncturing the tissue to be sampled. The distal cutting end 104 of theneedle 100 may be configured to cut and/or scrape target tissue tocollect cells, tissue, or fragments. To sample the target area, thebiopsy needle 100 may be guided to the tissue to be sampled through aninstrument positioned in a patient. The instrument may be used with anendoscope, conduit and/or medical device insertion instrument. As shown,the needle 100 may be positioned within a sheath 108 of an endoscopicdevice, for example, such that the biopsy needle 100 may be retractedand extended from the sheath 108.

Upon contacting the tissue to be sampled (via the distal cutting end104), the tissue sample may be collected within a lumen 112 of the shaft102. In some devices, the needle 100 may extend from the sheath 108 andinto the target tissue via a spring mechanism (not shown), such that thespring applies a force to the needle 100 and subsequently forces thedistal cutting end 104 into the target tissue. Upon making contact withthe target tissue, the distal cutting end 104 may separate a portion ofthe tissue from the surrounding tissue and collect the separated tissuewithin the lumen 112, which may result in a “core” sample (e.g., anumber of intact adjacent cells held together in similar form to theirnative location). Additionally, or alternatively, suction may be appliedto the proximal end of the needle 100 so as to aspirate the sample(e.g., cells, tissue, etc.) through the distal cutting end 104 of theneedle 100 and into the lumen 112.

Generally, the goal of FNA and/or FNB is to acquire sufficient tissue toallow a diagnosis to be made. Currently, different needle tipconfigurations are used to collect different sample types (e.g., intactmulti-cell samples useful for histology, cells and fragments useful forcytology, etc.). However, many existing biopsy needles are inefficientwhen collecting samples. For example, some needles use only about halfor less of their inner diameter of the lumen to obtain tissue. Further,some current needle tip designs generally result in tearing of targettissue, which may result in a less than ideal core sample andunnecessary trauma to the surrounding tissue, which may cause furthercomplications to the patient (e.g., internal bleeding, bruising, etc.)requiring further treatment.

Some devices that obtain a full cylinder or “full core” of tissue havedifficulty in withdrawing tissue and/or in maintaining the physicalstate of the tissue so as to provide an accurate assessment of tissuecondition. For example, some needles rely on scoring and/or mashingtechniques during tissue collection, which may result in a damagedtissue sample. Depending on the diagnostics, physical characteristics oftissue, such as placement or orientation of cells or tissue, may be asimportant or more important than the chemical or biologicalcharacteristics (e.g. presence of malignant cells or by-products).

Furthermore, current needle tip designs may be insufficient for biopsyof certain types of tissue. For example, some lesions are particularlyfibrous (e.g., pancreatic lesions) and are difficult to penetrate andobtain a suitable biopsy therefrom. Some bevel designs, such as thestandard beveled cutting end of needle 100, may initially pierce aportion of the target lesion, but may then deflect off of or drift fromthe target lesion due to the inadequate tip design and/or inability tofully penetrate the lesion, which results in a poor tissue sample, andmay even lead to damage to surrounding tissues or vital organs.Additionally, current bevel designs may merely shear off a portion ofthe target tissue and fail to collect some, or even all, of the sampledtissue within the lumen of the needle due to inadequate tip design.

SUMMARY

The present disclosure provides a biopsy needle configured to maximizetissue sampling yield and further ensure collection of a cohesive unitof sampled tissue, thereby overcoming the drawbacks of current biopsyneedles, which either provide an insufficient amount of a sample foranalysis and/or damage a sample during the collection process. Thebiopsy needle of the present disclosure is able to overcome thedrawbacks of current needles by providing a distinct distal cutting endconfigured to collect a full core of tissue sample and keep the fullcore intact. More specifically, the distal end includes at least a firsttip portion and a second tip portion that radially oppose one another oneither side of the needle body. The first tip portion is longer than thesecond tip portion, resulting in an increase in the surface area of acutting edge extending between the first and second tip portions,particularly when compared to the cutting surface of a beveled leadingdistal end of a conventional biopsy needle (e.g., see the needle ofFIGS. 1 and 2). Additionally, because the first tip portion is longerthan the second tip portion, the first tip portion is configured toinitially pierce the tissue to be sampled with little or no resistanceand further guide the sample tissue into the lumen of the biopsy needle.As the tissue is guided toward the lumen, second tip portion is furtherconfigured to capture and lead additional tissue towards the lumen to beexcised by the cutting edge upon contact therewith. By increasing theeffective cutting surface area and having the staggered configuration offirst and second tip portions, the biopsy needle of the presentdisclosure is able to guide tissue into the lumen in a controlled mannerand maximize the amount of tissue harvested, particularly uponaspiration.

In certain aspects, the present disclosure provides a biopsy needle thatgenerally includes an elongate tubular body having a longitudinal axisand has a lumen extending therethrough from a proximal open end to adistal open end of the body. The distal end includes first and secondtip portions extending therefrom. The first tip portion has a lengthgreater than the second tip portion, such that the first tip portion isconfigured to contact and engage tissue to be sampled prior to thesecond tip portion.

In some embodiments, the first tip portion is formed from a first set ofdistinct angular bevel grinds oblique to the longitudinal axis of thebody and the second tip portion is formed from a second set of distinctangular bevel grinds oblique to the longitudinal axis of the body. Insome embodiments, the first set of angular bevel grinds includes firstand second angles oblique to the longitudinal axis of the body and aback-cut angle oblique to an outer surface of the body for providing asmooth needle passage during needle insertion and withdrawal during abiopsy procedure. In some embodiments, the second set of angular bevelgrinds includes third and fourth angles oblique to the longitudinal axisof the body. The first and second angles of the first set of angularbevel grinds may be less than the third and fourth angles of the secondset of angular bevel grinds.

In some embodiments, the distal end further comprises at least onecurvilinear cutting edge extending from the first tip portion to thesecond tip portion, wherein the cutting edge is configured to excisetissue upon contact therewith. Additionally, each of the first andsecond tip portions defines a point configured to pierce the tissue tobe sampled and further direct tissue towards the lumen of the body to beexcised by the cutting edge upon contact therewith.

The biopsy needle of the present disclosure may be used in conjunctionwith minimally-invasive procedures, such as endoscopic biopsyprocedures. For example, the biopsy needle may be compatible with anendoscopic biopsy device, such as needle biopsy delivery deviceconfigured for endoscopic ultrasound or endoscopic bronchial ultrasoundprocedures.

In another aspect, the present disclosure includes a device for needlebiopsy. The device includes an adjustable delivery handle systemincluding a delivery handle, at least a portion of which comprises aninner lumen configured to receive one of a plurality of exchangeableneedle subassemblies. The adjustable delivery handle system furtherincludes a sheath coupled to a distal end of the handle and having alumen in fluid communication with the inner lumen of the deliveryhandle. The device further includes a needle subassembly removablydisposed within the inner lumen of the delivery handle and lumen of thesheath, the needle subassembly including an exchangeable biopsy needle.The biopsy needle generally includes an elongate tubular body having alongitudinal axis and has lumen extending therethrough from a proximalopen end to a distal open end of the body. The distal end includes firstand second tip portions extending therefrom. The first tip portion has alength greater than the second tip portion, such that the first tipportion is configured to contact and engage tissue to be sampled priorto the second tip portion.

In some embodiments, the first and second tip portions of theexchangeable needle radially oppose one another and are formed fromfirst and second sets of distinct angular bevel grinds oblique to thelongitudinal axis of the body, respectively. In some embodiments, thedistal end of the exchangeable needle further comprises first and secondcurvilinear cutting edges radially opposing one another and extendingfrom portions of the first tip portion to portions of the second tipportion. The cutting edges configured to excise tissue upon contacttherewith. In some embodiments, the biopsy needle further comprises acollet surrounding a portion of the body and has a diameter sufficientto prevent the body from entirely passing through a distal end of thesheath of the adjustable delivery handle system.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a biopsy needle knownin the art.

FIG. 2 is a cross-sectional view of the biopsy needle of FIG. 1.

FIG. 3 is a perspective view of a portion of a biopsy needle consistentwith the present disclosure.

FIG. 4 is a perspective view of a portion of a biopsy needle consistentwith the present disclosure.

FIG. 5 is an enlarged side profile view of the distal end of the biopsyneedle of FIGS. 3 and 4.

FIG. 6 is a bottom view of the distal end of the biopsy needle of FIGS.3 and 4.

FIG. 7 is an enlarged side profile view of an alternative embodiment ofa distal end of a biopsy needle consistent with the present disclosure.

FIG. 8 is a perspective view of a biopsy device including an adjustabledelivery handle and sheath for receipt of and use with an exchangeablebiopsy needle consistent with the present disclosure.

FIG. 9 is a drawing of the needle sub-assembly of the device of FIG. 8.

FIG. 10 is a cross sectional drawing of the needle protector embodimentof the needle sub-assembly of FIG. 9.

FIG. 11 is a cross sectional drawing of the needle hub at the proximalend of the biopsy needle sub-assembly of FIG. 9.

FIG. 12 is a perspective view of a biopsy needle consistent with thepresent disclosure.

FIG. 13A is a side view, partly in section, of storage of the biopsyneedle of FIG. 12 within the sheath of FIG. 8.

FIG. 13B is a side view, partly in section, of extension of the biopsyneedle of FIG. 12 from the sheath of FIG. 8.

FIG. 14 is a perspective view illustrating the initiation of sampletissue collection with a biopsy needle consistent with the presentdisclosure.

DETAILED DESCRIPTION

By way of overview, the present disclosure is generally directed to abiopsy needle configured for collecting tissue, fluid, and/or cellsamples in conjunction with minimally-invasive procedures, such asendoscopic biopsy procedures. As described in greater detail herein, abiopsy needle consistent with the present disclosure may be used inEndoscopic Ultrasound (EUS) and Endobronchial Ultrasound (EBUS)procedures, particularly EUS Fine Needle Aspiration (FNA), EUS FineNeedle Biopsy (FNB), EUS Coring, and EBUS procedures for the purpose ofharvesting tissue specimen from a targeted site. It should be noted,however, that the biopsy needle may be used in other minimally-invasiveprocedures, and is not limited to EUS and/or EBUS procedures.

In one aspect, a biopsy needle consistent with the present disclosureincludes an elongate tubular body having a longitudinal axis and a lumenextending therethrough from a proximal open end to a distal open end ofthe body. The distal end includes at least a first tip portion and asecond tip portion that radially oppose one another on either side ofthe needle body. The first tip portion is longer than the second tipportion, resulting in an increase in the surface area of a cutting edgeextending between the first and second tip portions, particularly whencompared to the cutting surface of a beveled leading distal end of aconventional biopsy needle (e.g., see the needle of FIGS. 1 and 2).

Because the first tip portion is longer than the second tip portion, thefirst tip portion is configured to initially pierce the tissue to besampled with little or no resistance and further guide the sample tissueinto the lumen of the biopsy needle. As the tissue is guided toward thelumen, the second tip portion captures and leads additional tissuetowards the lumen. During this process the tissue is excised by thecutting edge, creating a contiguous core biopsy sample. By increasingthe effective cutting surface area and having the staggeredconfiguration of first and second tip portions, the biopsy needle of thepresent disclosure is able to guide tissue into the lumen in acontrolled manner and maximize the amount of tissue harvested,particularly upon aspiration.

The distinct distal cutting end of a biopsy needle consistent with thepresent disclosure is configured to collect a full core of tissue samplewhile keeping the full core intact. Accordingly, a biopsy needleconsistent with the present disclosure is configured to maximize tissuesampling yield and further ensure collection of a cohesive unit ofsampled tissue so as to provide a more complete sample for testing,which may improve the accuracy and/or timing of diagnosis.

FIGS. 3 and 4 show a distal portion a biopsy needle 200 consistent withthe present disclosure. As shown, the needle 200 generally includes anelongate tubular body 202 having a lumen 203 extending through the body202 from a proximal open end (not shown) to a distal open end 204. Thedistal end 204 is configured for collection and harvesting of a sample,including, but not limited to, tissue, fluid, and/or cell samples. Inparticular, the distal end 204 is beveled in a distinct configuration soas to enhance the ability of the needle 200 to penetrate and collecttissue during sample acquisition.

The distal end 204 includes a first tip portion 206 and a second tipportion 210 extending therefrom, wherein the first and second tipportions 206, 210 are formed on opposing sides of the needle body 202,such that the tip portions radially oppose one another. The first andsecond tip portions 206, 210 each include a point 208, 212,respectively. The points 208, 212 are configured to penetrate a tissuesample, with relatively little or no resistance during tissue samplingprocedure and further configured to direct tissue towards the lumen 203of the body 202.

The first tip portion 206 is generally formed from at least a firstbevel 214 grind (shown on one side of the needle body 202) and thesecond tip portion 210 is formed from at least a second bevel grind 216,wherein the first and second bevel grinds 214, 216 are different fromone another. The differing bevel grinds 214, 216 result in differentlengths of the first and second tip portions 206, 210. For example, thefirst tip portion 206 has a length L₁ and the second tip portion 210 hasa length L₂. The lengths L₁ and L₂ are each measured from an apex of anarcuate cutting edge shared between the first and second tip portions206, 210 (shown in FIG. 6) and the corresponding tips 208, 212. In theillustrated embodiment, L₁ is greater than L₂, such that the first tipportion 206 is essentially longer and extends further from apex than thesecond tip portion 210, such that the first and second tip portions 206,210 are in a staggered configuration. As such, the first tip portion 206is configured to contact and engage tissue to be sampled prior tocontact and engagement of tissue by the second tip portion 210, whichprovides associated benefits, as will be described in greater detailherein. In some embodiments, at least one of the first and second tipportions 206, 210 includes a back-cut grind 218, 220 adjacent therespective point 208, 212. Among other benefits, the back-cut grind 218,220 is configured to provide a smooth needle passage during needleinsertion and withdrawal during a biopsy procedure, described in greaterdetail herein.

The distal end 204 further includes at least one curvilinear, orarcuate, cutting edge 222 extending between the first tip portion 206and the second tip portion 210. The cutting edge 222 is generally formedby the first and second bevel grinds 214, 216 of the first and secondtip portions 206, 210. During a tissue collection procedure, the cuttingedge 222 is configured to excise tissue upon contact therewith andfurther allow the excised tissue sample to translate into the lumen 203and contact the internal surface 224 of the lumen 203 for harvesting.

FIG. 5 is an enlarged side profile view of the distal end 204 of thebiopsy needle 200. As shown, the cutting edge 222 generally extendsentirely from the point 208 of the first tip portion 206 to the point212 of the second tip portion 210. However, it should be noted that inother embodiments, the cutting edge 222 may only partially extendbetween distinct portions of the first and second tip portions 206, 210.In one embodiment, at least one of the first and second tip portions206, 210 includes a back-cut grind. In another embodiment, i.e., asshown in the figures, both the first and second tip portions 206, 210include a back-cut grind 218, 220, respectively. Each back-cut grind218, 220 includes a back-cut angle oblique to an outer surface of theneedle body 202. For example, back-cut grind 218 has a back-cut angle Aand back-cut grind 220 has a back-cut angle B, wherein angles A and Bare in the range of 15 degrees to 70 degrees, but more preferably in therange of 25 degrees to 45 degrees. In one embodiment, the back cutangles A and B are 30 degrees.

The inclusion of at least back-cut grind 218 on the first tip portion206 may ensure the smooth passage of the needle down a sheath, or otherenclosure of a delivery device, during needle movement and/or exchange.For example, the biopsy needle 200 of the present disclosure may be usedin conjunction with a delivery device, such as an endoscopic device fordelivering the needle 200 to the target site for tissue collection. Theendoscopic device may generally include a sheath, or other enclosure,for provide the needle 200 with access to a target site for tissuecollection. As such, during a needle exchange, for example, it isimportant that the needle 200 can be passed through an internal diameterof a sheath of the delivery device without catching on an internal wallof the sheath. As the needle advances, the heel of the back-cut grind218 may come in contact with the internal diameter of the sheath andreduce the friction between the distal end 204 of the needle 200,particularly the point 208 of the first tip portion 206, and the sheath.In this way, the needle 200 can be smoothly tracked through the sheathto exit the end of the sheath. This feature also makes it easy to removea needle and re-insert a new needle while the rest of a delivery deviceremains within a patient during a procedure.

FIG. 6 is a bottom view of the distal end 204 of the biopsy needle 200illustrating sets of bevel grinds that form the distal end 204. Asshown, the first and second tip portions 206, 210 are formed from firstand second sets of distinct angular bevel grinds that enhance tissuepenetration and collection. For example, the first tip portion 206 isformed from a first set of distinct angular bevel grinds oblique to thelongitudinal axis X of the needle body 202. The first set of angularbevel grinds comprises at least a first angle C on one side of the body202 and a second angle C′ on the opposing side of the body 202, whereinboth angles C and C′ are oblique to the longitudinal axis X of the body202. In one embodiment, angles C and C′ may be the same. In otherembodiments, angles C and C′ may be different. The first and secondangles C and C′ are in the range of 5 to 40 degrees. In someembodiments, the first and second angles C and C′ are in the range of 5to 20 degrees. In one embodiment, the first and second angles C and C′are 15 degrees.

Similarly, the second tip portion 210 is formed from a second set ofdistinct angular bevel grinds oblique to the longitudinal axis X of theneedle body 202. The second set of angular bevel grinds comprises atleast a third angle D on one side of the body 202 and a fourth angle D′on the opposing side of the body 202, wherein both angles D and D′ areoblique to the longitudinal axis X of the body 202. In one embodiment,angles D and D′ may be the same. In other embodiments, angles D and D′may be different. The third and fourth angles D and D′ are in the rangeof 15 to 40 degrees. In some embodiments, the third and fourth angles Dand D′ are in the range of 20 to 30 degrees. In one embodiment, thethird and fourth angles D and D′ are 25 degrees.

In the illustrated embodiment, the first and second sets of angularbevel grinds are different than one another. For example, in oneembodiment, the first and second angles C and C′ (forming the first tipportion 206) are approximately 15 degrees and the third and fourthangles D and D′ (forming the second tip portion 210) are approximately25 degrees. Accordingly, the first and second angles C and C′ are lessthan the third and fourth angles D and D′, resulting in the first andsecond tip portions 206, 210 having different associated lengths. Forexample, the first tip portion 206 has a length L₁ (measured from thetip 208 to an apex of the arcuate cutting edge 222) and the second tipportion 210 has a length L₂ (measured from the tip 212 to an apex of thearcuate cutting edge 222), wherein L₁ is greater than L₂. Accordingly,the first tip portion 206 is longer and extends further from the distalend 204 than the second tip portion 210, such that the first and secondtip portions 206, 210 are in a staggered configuration and the first tipportion 206 leads during tissue collection. More specifically, the firsttip portion 206 is configured to contact and engage tissue to be sampledprior to contact and engagement of tissue by the second tip portion 210.The lengths L₁ and L₂ of the first and second tip portions 206, 210 arein the range of 0.5 to 5 mm. In some embodiments, the length L₁ is inthe range of 2 to 3 mm and the length L₂ is in the range of 0.5 to 1.5mm. In one embodiment, the first tip portion 206 has a length L₁ ofapproximately 2.0618 mm and the second tip portion 210 has a length L₂of approximately 1.3 mm. It should be noted that the first and secondsets of angular bevel grinds may be manipulated so as to result inadjustment of lengths L₁ and L₂ of the first and second tip portions,respectively.

The distinct configuration of the distal end 204 of the biopsy needle200 is configured to maximize tissue sampling yield and further ensurecollection of a cohesive unit of sampled tissue, thereby overcoming thedrawbacks of current biopsy needles (such as needle 100 of FIGS. 1 and2). For example, by providing a staggered configuration of the first andsecond tip portions 206, 210, the surface area of the effective cuttingedge 222 is increased when compared to beveled leading distal ends pfcurrent biopsy needles (e.g., Menghini, Franseen, Quicke, etc.).Additionally, because the first tip portion 206 is longer than thesecond tip portion 210, the first tip portion 206 is configured toinitially pierce the tissue to be sampled with little or no resistanceand further guide the sample tissue into the lumen 203 of the biopsyneedle 200. If the first and second tip portions 206, 210 were of equallength, it may prove more difficult to initially puncture of tissuesample, particularly a fibrous tissue. Furthermore, as the tissue isguided toward the lumen 203, second tip portion 210 is furtherconfigured to capture and lead additional tissue towards the lumen 203to be excised by the cutting edge 222 upon contact therewith. Byincreasing the effective cutting surface area and having the staggeredconfiguration of first and second tip portions 206, 210, the biopsyneedle 200 of the present disclosure is able to guide tissue into thelumen in a controlled manner and maximize the amount of tissueharvested, particularly upon aspiration.

It should be noted that a biopsy needle consistent with the presentdisclosure is not limited to the number of tip portions (e.g., two tipportions). For example, FIG. 7 is an enlarged side profile view of analternative embodiment of a distal end 304 of a biopsy needle 300 havingat least four tip portions extending from the distal end. As shown, theneedle 300 may include first and second tip portions 306, 314 (similarto needle 200), and an additional third 310 and fourth (not shown) tipportion formed between the first and second tip portions 306, 314,wherein the first and second tip portions 306, 314 radially oppose oneanother on either side of the needle body 302 and the third and fourthtip portions radially oppose one another on either side of the needlebody 302. As shown, the first tip portion 306 is longer than the third(and fourth) tip portion 310, which is longer than the second tipportion 314, such that distal end 304 maintains a staggeredconfiguration. The inclusion of additional tip portions may furtherincrease the surface area of cutting edges 320, 324 formed between thetip portions, which may be particularly beneficial when sampling certaintypes of tissue that may prove to be tough or resistant to cutting(e.g., fibrous tissue).

The biopsy needle of the present disclosure may be used in conjunctionwith minimally-invasive procedures, such as endoscopic procedures. Forexample, the biopsy needle may be compatible with an endoscopic biopsydevice, such as needle biopsy delivery device configured for endoscopicultrasound or endoscopic bronchial ultrasound procedures. For example,the biopsy needle may be compatible for use with exemplary endoscopicdeliver systems and methods discussed in Needle Biopsy Device withExchangeable Needle and Integrated Needle Protection, U.S. Pub.2012/0116248, Rapid Exchange FNA Biopsy Device with Diagnostic andTherapeutic Capabilities, U.S. Pub. 2011/0190662, Device for NeedleBiopsy with Integrated Needle Protection, U.S. Pub. 2010/0121218, andNeedle Biopsy Device, U.S. Pub. 2010/0081965, the contents of each ofwhich are hereby incorporated by reference in their entirety.

An exemplary embodiment of an endoscopic delivery device assembly foruse with a biopsy needle of the present disclosure is illustrated inFIG. 8. The device and specific delivery methods are discussed in moredetail in Needle Biopsy Device with Exchangeable Needle and IntegratedNeedle Protection, U.S. Pub. 2012/0116248, the contents of which arehereby incorporated by reference in their entirety. The device designconsists of a handle mechanism (delivery system handle 10) and removableneedle sub-assembly 15. The delivery system handle 10 includes aproximal handle member 10 a, a middle handle member 10 b, and a distalhandle member 10 c. The proximal, middle and distal handle members eachinclude an inner lumen and are coupled together to define a longitudinalaxis such that the inner lumens are in constant communication andextends throughout the length of the coupled handle members. Proximalhandle member 10 a is slideably disposed over at least a portion of themiddle handle member 10 b, and middle handle member 10 b is slideablydisposed over at least a portion of distal handle member 10 c. Theproximal handle member 10 a includes proximal handle grip 10 a 1 adistal handle grip 10 a 2. The delivery handle system 10 furtherincludes an inner handle member 10 d disposed within the inner lumen ofthe middle handle member 10 b.

The delivery system handle 10 also incorporates a sheath 14 componentcoupled to the distal end of the distal handle member 10 c. Thiscomponent provides a conduit between the delivery system handle 10 andthe target sampling site during the exchange of needles, such as thebiopsy needle previously described herein. The device design is modularin that the needle sub-assembly 15 can be detached from the proximalhandle 10 a of the device for each individual “pass” or aspirated sampletaken by the endoscopist at the site of the lesion or abnormality.

The delivery system handle 10 incorporates two length adjustmentfeatures actuated via adjustment of two thumbscrew locking mechanisms. Athreaded proximal thumbscrew 12 and locking ring 33 are moveablydisposed around the middle handle member 10 b, the proximal thumbscrew12 is loosened to loosen locking ring 33, locking ring 33 is moveddistally along the middle handle member 10 b and tightened in thedesired position along middle handle member 10 b via proximal thumbscrew12 to allow the user to establish a set depth of needle penetrationbeyond the end of the sheath 14. A threaded distal thumbscrew 13 istransversely disposed at the distal portion of the middle handle member10 b, the distal thumbscrew 13 is loosened to move the middle handlemember 10 b distally and/or proximally and tightened to allow the userto establish a set depth of sheath 14 extension beyond the end of theendoscope accessory channel.

The needle sub-assembly 15 consists of at least a biopsy needleconsistent with the present disclosure (e.g., needle 200). The body 202of needle 200 can range in length from 200 mm up to 2500 mm. In someembodiments, the needle body 202 can range in length between 500 mm to2000 mm. In some embodiments, the needle body 202 can range in lengthbetween 800 mm to 1800 mm. In some embodiments, the needle body 202 canrange in length between 1640 mm to 1680 mm. The needle sub-assembly 15further includes needle hub 17, needle luer 18, needle collet 226,needle protector sub-assembly 9, stylet hub 20, and stylet shaft 22.

As generally understood, the needle 200 itself can be manufactured froma variety of metallic based materials, including, but not limited to,nitinol, cobalt chrome, stainless steel, a metal alloy, combinationsthereof, or Polymeric Based materials including, but not limited topoly-ether-ether ketone, polyamide, poyethersulfone, polyurethane, etherblock amide copolymers, polyacetal, polytetrafluoroethylene and/orderivatives thereof. It should be noted that the biopsy needle is notlimited to any particular gauge (e.g., outer diameter). For example,depending on the type of sample to be collected, as well as the targetsite from which the sample is to be collected, the biopsy needle mayrange from 10-gauge to 30-gauge, and more specifically 15-gauge to28-gauge, i.e., gauge 12, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or25 needles.

FIG. 9 is a drawing of the needle sub-assembly 15 of the device of FIG.8. The sub-assembly 15 is inserted into and removed from the lumen ofthe delivery system handle 10 in acquiring tissue samples. Thesub-assembly 15 consists of stylet hub 20 and stylet shaft 22 componentswhich are securely locked on the needle luer 18 of the needle 200 viaconventional internal luer threads, as generally understood by oneskilled in the art. The stylet hub 20 may be attached to the styletshaft 22 via any known processing techniques, including, but not limitedto, adhesive bonding or insert injection molding. The female luer of theneedle 200 incorporates a mating luer thread detail, onto which thestylet hub 20 may be tightened. The needle luer 18 element of thepresent disclosure may be attached to the proximal end of the needleshaft via a number of processing techniques such as adhesive bonding orinsert injection molding.

The removable needle sub-assembly 15 also incorporates a needle collet226. The function of this needle collet 226 is to provide a means tocenter the needle body 202 in the sheath 14 of the delivery systemduring needle exchange and provide a mechanism for securing and lockingthe needle protector sub-assembly to the distal end 204 needle 200 oncethe needle 200 has been unlocked and withdrawn from the delivery systemhandle. The needle collet 226 of the present disclosure may be attachedto a portion of the needle body 202 near the distal end 204 of theneedle 200 by way of any known processing techniques, including, but notlimited to, adhesive bonding, laser welding, resistance welding, insertinjection molding, and combinations thereof. The needle collet 226 maybe fabricated from metals materials such as stainless steel, nickeltitanium or alloys thereof or polymer materials such as, but not limitedto, Polyacetal, polyamide, poly-ether-block-amide, polystyrene,Acrylonitrile butadiene styrene or derivatives thereof.

FIG. 10 illustrates the needle protection sub-assembly 9 designembodiment of the present disclosure in the locked position at thedistal end 204 of the needle 200. The needle protection sub-assembly 9consists of two needle protector (NP) hub halves (collectively 23),which are adhesively bonded to each other, on the proximal end of theneedle protector (NP) sheath component 24. Alternatively, the NP hubhalves 23 may be snap fit together or may be insert injection moldedover the NP sheath 24 to provide a secure bond/attachment between thesecomponents in the assembly. The needle protection sub-assembly 9 alsoincorporates a needle protector (NP) hub O-Ring component 25. The O-Ringcomponent resides in a recessed cut-out in the center of the assembledNP hub halves 23. The NP hub O-Ring 25, in conjunction with the needlecollet 226, which is securely attached to a portion of the needle body202 near the distal end 204 of the needle 200, provides a mechanism forlocking the NP sub-assembly 9 onto the end of the needle 200. In thisway, the distal cutting end 204, including the first and second tipportions 206, 210 previously described herein, is protected, covered andshielded once the needle has been removed from the delivery systemhandle. For example, upon acquiring a sample from a target site, theneedle 200 may be removed so as to gain access to the sampled materialfor testing and diagnostic procedures. The needle 200 may be continuallywithdrawn from the delivery system handle 10, such that the needlecollet 226 contacts the NP hub O-ring 25 and further pulls the NPsub-assembly 9 from engagement with needle hub 17, such that the needle200 is completely removed from the delivery system handle 10 and the NPsheath 24 encases the distal end 204 of the needle 200 to preventinadvertent “needle sticking”. Further, an operator may then pull backthe NP sub-assembly 9 from the distal end 204 of the needle 200 so as tocollect the sampled material stored within the lumen of the needle 200.Accordingly, the NP sub-assembly 9 is configured to translate along alength of the needle 200 so as to allow access to the distal end 204 ofthe needle 200 post acquisition and when the needle 200 is entirelyremoved from the delivery system handle 10.

Referring the FIG. 11, the needle hub 17 embodiment of the needlesub-assembly is generally illustrated. The needle hub 17 provides amechanism configured to lock the removable needle sub-assembly 15 intothe delivery system handle 10 by means of the hub housing 27 and thumblatch 28 components and provide a means to lock the needle protectionsub-assembly 9 embodiment shown in FIG. 10, into the delivery systemdevice handle 10. As shown in FIG. 11, the needle hub component 17 issecurely attached to the needle luer 18 and needle body 202. The needlehub element 17 of the present disclosure may be attached to the distalend of the needle luer component 18 via a number of processingtechniques such as adhesive bonding or insert injection molding.

In some instances, it may be preferable to switch needles during aprocedure, while still maintaining access to the target site. Thedelivery system of FIG. 8 is configured to allow rapid needle exchangeswithout requiring the delivery system to be removed from the scope, asdescribed in greater detail in U.S. Pub. 2012/0116248, the contents ofwhich are hereby incorporated by reference in their entirety.Accordingly, the sheath 14 may remain at a target site for an indefiniteperiod of time while allowing the exchange of multiple needles. Therapid needle exchange capabilities provided by the delivery system ofthe present disclosure may further decrease the amount of time requiredfor a biopsy procedure, which may cut down the amount of anesthesiarequired during a particular procedure, improving patient safety.Additionally, a new biopsy device is not required for each needle, asmay be the case with current biopsy devices and techniques. Accordingly,the delivery system and exchangeable needles of the present disclosurecan cut down on costs and by preventing unnecessary waste.

FIG. 12 is a perspective view of a portion of the biopsy needle near thedistal end. As shown, the needle 200 further includes collet 226 coupledto a portion of the needle body 202. The length of the needle collet 226may be in the range of 2 mm to 10 mm, but more preferably in the rangeof 3.5 mm to 5 mm. It is preferable that the outer diameter of theneedle collet 226 be in the range of 0.030 inches to 0.080 inches, butmore preferably in the range of 0.040 inches to 0.070 inches, dependingon the gauge of the needle 200. The needle collet component 226 may bechamfered at the proximal and distal ends thereof. In some embodiments,it may be preferable that the chamfer angle of the needle collet 226 bein the range of 15 degrees to 80 degrees, oblique to a longitudinal axisof the needle 200, but more preferably in the range of 30 degrees to 60degrees. The chamfer on both ends of the needle collet 220 may providesmooth locking and unlocking with the needle protector sub-assembly 9during needle exchanges.

The needle collet 226 is located at a set point distance from the distalend 204 of the needle 200. The distance from the distal end 204 of theneedle to the proximal collet position on the needle 200 may be withinthe range of 6 cm to 12 cm, but is more preferably in the range of 7 cmto 9 cm, and more preferably is located 8 cm from the end of the needle200. This ensures that when the needle is extended to a maximumextension distance relative to the distal end 14 a of the sheath (i.e. 8cm), the collet 226 does not exit the end of sheath 14, as shown inFIGS. 13A and 13B.

In the illustrated embodiment, a portion 228 of the needle body 202adjacent the distal end 204 may incorporate an embodiment to enhance theechogenic signature of the needle 200. For example, this echogenicallyenhanced region 228 can be fabricated by, but not limited to, rougheningthe end of the needle over a pre-defined length adjacent to at least thefirst and second tip portions of the distal end 204. The length of theechogenically enhanced region 228 may be in the range of 2 mm to 20 mm,but is more preferably in the range of 10 mm to 15 mm. The echogenicenhanced pattern 228 may be imparted to the needle body 202 via amicro-blasting process which roughens the surface of the needle over aspecific length, improving the visibility of the needle under endoscopicultrasound. In other embodiments, the echogenically enhanced region 228of the needle 200 may be achieved through the removal of material fromthe surface of the needle to provide greater reflectivity andstrengthened reflected signal. It is contemplated that the removal ofmaterial does not, however, reduce the performance of the needle from apushability perspective or deter its ability to acquire a desiredsample.

FIGS. 13A and 13B are side views, partly in section, of storage andextension of the biopsy needle 200 of FIG. 12 within the sheath 14 ofthe delivery system of FIG. 8. Referring to FIG. 13A, the needle 200 isshown loaded within the sheath 14 with the device handle in the fullyretracted position and ready for extension into a target site for samplecollection. In this instance, the distal end 204 of the needle 200 liesproximal to the distal tapered end 14 a of the sheath 14. FIG. 13Billustrates the position of the needle 200 and needle collet 226relative the sheath 14 when the needle transitions to a fully extendedposition, as indicated by arrow 230. In the fully extended position, theneedle collet 226 remains housed inside sheath 14, proximal to thetapered distal tip, thereby preventing the needle 200 from extendingpast a set distance from the sheath 14.

It is important, particularly during tissue collection procedures and/orneedle exchange, that the needle 200 can be passed through an internaldiameter of a sheath 14 of the delivery device without catching on aninternal wall of same. As the needle advances, the heel of the back-cutgrind 218 on the first tip portion 206, for example, may come in contactwith the internal diameter of the sheath 14 and reduce the frictionbetween the distal end 204 of the needle 200, particularly the point 208of the first tip portion 206, and the sheath 14. In this way, the needle200 can be smoothly tracked through the sheath to exit the end of thesheath.

FIG. 14 is a perspective view illustrating the initiation of sampletissue collection with a biopsy needle 200. As shown, the needle 200 maybe extended from the sheath 14 when delivered to a target site. Anoperator (e.g., physician or other trained medical personnel) may thenadvance the distal end 204 of the needle 200 towards the target tissue232 to be sampled (with or without the assistance of use of ultrasoundtechniques). As shown, because the first tip portion 206 has a greateroverall length than the second tip portion 210, the point 208 of thefirst tip portion 206 of the distal end 204 contacts and engages thetissue 232, as indicated by arrow 234. The first tip portion 206 isconfigured to pierce the tissue 232 further direct a tissue sample 236in a direction towards the lumen 203, as indicated by arrow 238. As theneedle is forced further into the target tissue 232, the second tipportion 210, which is set back from the first tip portion 206, isconfigured to catch and grab additional tissue that may have otherwisedeflected off of the first tip portion 206 and may have missed the lumen203 entirely, as is the case with some current needle tip designs. Forexample, as tissue is excised by the cutting edge 222 after initialpuncture by the tip 208 of the first tip portion 206, the excised tissuemay curl away from the first tip portion 208. The shorter second tipportion 210 is then configured to catch and collect the deflectedexcised tissue, as indicated by arrow 240, and further pierce the targettissue 232, thereby guiding a tissue sample 236 towards the lumen 203and to be further excised by the cutting edge 22 upon contact therewith,as indicated by arrow 242. In this manner, a full core sample may beachieved. In one embodiment, a vacuum may be communicated from theproximal end to the distal end 204 through the lumen 203 so as toprovide a suction force to the target tissue 232 and further assist incollection and harvesting of the tissue sample 238 via aspiration.

While several embodiments of the present disclosure have been describedand illustrated herein, those of ordinary skill in the art will readilyenvision a variety of other means and/or structures for performing thefunctions and/or obtaining the results and/or one or more of theadvantages described herein, and each of such variations and/ormodifications is deemed to be within the scope of the presentdisclosure. More generally, those skilled in the art will readilyappreciate that all parameters, dimensions, materials, andconfigurations described herein are meant to be exemplary and that theactual parameters, dimensions, materials, and/or configurations willdepend upon the specific application or applications for which theteachings of the present disclosure is/are used.

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents to the specificembodiments of the disclosure described herein. It is, therefore, to beunderstood that the foregoing embodiments are presented by way ofexample only and that, within the scope of the appended claims andequivalents thereto, the disclosure may be practiced otherwise than asspecifically described and claimed. The present disclosure is directedto each individual feature, system, article, material, kit, and/ormethod described herein. In addition, any combination of two or moresuch features, systems, articles, materials, kits, and/or methods, ifsuch features, systems, articles, materials, kits, and/or methods arenot mutually inconsistent, is included within the scope of the presentdisclosure.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Other elements may optionallybe present other than the elements specifically identified by the“and/or” clause, whether related or unrelated to those elementsspecifically identified, unless clearly indicated to the contrary.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

The terms and expressions which have been employed herein are used asterms of description and not of limitation, and there is no intention,in the use of such terms and expressions, of excluding any equivalentsof the features shown and described (or portions thereof), and it isrecognized that various modifications are possible within the scope ofthe claims. Accordingly, the claims are intended to cover all suchequivalents.

Incorporation by Reference

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

Equivalents

Various modifications of the invention and many further embodimentsthereof, in addition to those shown and described herein, will becomeapparent to those skilled in the art from the full contents of thisdocument, including references to the scientific and patent literaturecited herein. The subject matter herein contains important information,exemplification and guidance that can be adapted to the practice of thisinvention in its various embodiments and equivalents thereof.

What is claimed is:
 1. A device for needle biopsy comprising: anadjustable delivery handle system comprising: a delivery handle, atleast a portion of which comprises an inner lumen configured to receiveone of a plurality of exchangeable needle subassemblies; and a sheathcoupled to a distal end of the handle and having a lumen in fluidcommunication with the inner lumen of the delivery handle; and a needlesubassembly removably disposed within the inner lumen of the deliveryhandle and lumen of the sheath, the needle subassembly comprising anexchangeable biopsy needle comprising: an elongate tubular bodycomprising a lumen extending therethrough from a proximal open end to adistal open end of the body, the distal end comprising a first tipportion extending from the distal end and having a first length and asecond tip portion extending from the distal end and having a secondlength that is less than the first length of the first tip portion, suchthat the first tip portion is configured to contact and engage tissue tobe sampled prior to the second tip portion.
 2. The device of claim 1,wherein the first and second tip portions of the needle radially opposeone another and are formed from first and second sets of distinctangular bevel grinds oblique to the longitudinal axis of the body,respectively.
 3. The device of claim 2, wherein the first and secondsets of angular bevel grinds are different from one another.
 4. Thedevice of claim 1, wherein the distal end of the needle furthercomprises first and second curvilinear cutting edges radially opposingone another and extending from portions of the first tip portion toportions of the second tip portion, the cutting edges configured toexcise tissue upon contact therewith.
 5. The device of claim 1, whereinthe needle further comprises a collet surrounding a portion of the bodyand having a diameter sufficient to prevent the body from entirelypassing through a distal end of the sheath of the adjustable deliveryhandle system.
 6. The device of claim 5, wherein the needle subassemblyfurther comprises a needle protector subassembly releasably coupled tothe collet of the needle.
 7. The device of claim 6, wherein the needleprotector subassembly comprises a sheath for encasing the distal end ofthe needle upon withdrawal of the needle from the delivery handle andfor preventing inadvertent puncture from at least one of the first andsecond tip portions of the distal end of the needle.
 8. The device ofclaim 7, wherein the sheath is moveable along a length of the needlebody and configured to be retracted in a proximal direction to exposethe distal end of the needle for removal of acquired tissue sample fromthe lumen of the needle.
 9. The device of claim 6, wherein the needleprotector subassembly comprises: a needle protection hub having a lumenextending therethrough and configured for receiving at least the distalend of the needle; a deformable O-ring axially disposed within the lumenof the needle protection hub and configured for releasably coupling tothe collect of the needle; and a tubular sheath defining a lumenextending from a distal end of the needle protection hub, the lumen ofthe tubular sheath in communication with the lumen of the needleprotection hub for receiving the needle when inserted into the needleprotection hub.
 10. The device of claim 9, wherein the sheath isconfigured to encase the distal end of the needle upon withdrawal of theneedle from the delivery handle and for preventing inadvertent puncturefrom at least one of the first and second tip portions of the distal endof the needle.
 11. The device of claim 10, wherein the sheath ismoveable along a length of the needle body and configured to beretracted in a proximal direction to expose the distal end of the needlefor removal of acquired tissue sample from the lumen of the needle. 12.The device of claim 1, wherein the lumen of the needle is configured tocommunicate a vacuum from the proximal end to the distal end of theneedle body to provide a suction force to the tissue to be sampled. 13.The device of claim 1, wherein each of the first and second tip portionsof the needle defines a point configured to pierce the tissue to besampled and further direct tissue towards the lumen of the needle body.14. The device of claim 1, further comprising a section of the needlebody adjacent to the distal end and having enhanced echogenicity oracoustic reflection.
 15. The device of claim 1, wherein the needle bodyhas an outer diameter in the range of 10-gauge to 30-gauge.
 16. Thedevice of claim 1, wherein the needle is comprised of a materialselected from the group consisting of nitinol, cobalt chrome, stainlesssteel, a metal alloy, and combinations thereof.